A Quality Infrastructure To Support Clinical Research Professionals

Jessica Truett

The clinical research enterprise fuels the health care industry with the required data to support data-driven health care decisions. Clinical research requires skilled clinical research professionals (CRPs) to facilitate clinical investigations, leading to peer-reviewed publications from clinical research trials (Berger et al., 2021). These publications are the cornerstone of advancing academic medicine, such as orthopedic interventions, which was the focus of the research organization of this research project (Berger et al., 2021). Further, CRPs work in various settings that require collaboration with medical professionals and high work demands that require a high level of quality (Flores Luna et al., 2023; Mascaro et al., 2021). However, clinical research has been experiencing a crisis due to insufficient infrastructure to support CRPs in the field (Freel et al., 2023; Stabile et al., 2023).The clinical research field currently lacks the infrastructure to support CRPs at the organizational and national levels, as evidenced by the lack of clearly defined roles (Mitchell et al., 2022; Stabile et al., 2023). The roles of CRPs have not been formalized, recognized, or valued in the past, contributing to the problem of establishing quality-based clinical research organizations, meeting the CRP demand, and a high level of turnover of CRPs (Freel et al., 2023; Mitchell et al., 2022). The ratio of experienced CRPs to available positions in the United States was 1:7 as of 2023 (Freel et al., 2023). Researchers have hypothesized that the field’s high demands and frequently changing landscape may contribute to the lack of CRPs available to fulfill the demand of the field (Association of Clinical Research Professionals, 2020; Stroo et al., 2020). The high level of CRP turnover aligns with the lack of clearly defined tasks of CRPs (Flores Luna et al., 2023; Fu et al., 2021; Majkut Klint et al., 2021; Mitchell et al., 2022). When an incongruency is present between CRPs’ values and organizational values, a higher risk of x burnout exists for CRPs, contributing to turnover (Majkut Klint et al., 2021). Therefore, aligning clinical research organizations’ definitions and expectations of their CRPs can reduce the likelihood of incongruency and reduce CRP turnover by creating a quality-focused infrastructure for CRPs. The setting of this research initiative was an orthopedically focused clinical research organization. The research question for this study was to investigate how an orthopedic clinical research organization could create a quality-driven infrastructure to support CRPs and reduce turnover. I conducted an environmental, gap, and cause analysis of the organization related to the infrastructure to support the CRPs. These methodologies align with the human performance technology (HPT) model for performance improvement. The HPT model encompasses techniques, interventions, and approaches to solve applied problems in human performance systematically and collaboratively (Pershing, 2006; Van Tiem et al., 2012). The environmental analysis included evaluating existing organizational practices compared to the expected practices and was assessed quantitatively through CRP scores in Good Clinical Practice (GCP) and qualitatively through a Quality of Practice questionnaire. The evaluation of the present level of practice compared to the expected practice levels uncovered gaps in CRP knowledge and clarity in job roles. Next, I conducted a cause analysis and identified the root causes for the present gaps. Then, I used a collaborative team approach to identify interventions to target the identified causes for the gaps. I initiated a self-directed learning intervention to close the gap in GCP knowledge for the CRPs and strategic planning interventions to provide performance support tools and job task analysis to address the gap in job role clarity for CRPs.

A Quality Infrastructure To Support Clinical Research Professionals

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A Quality Infrastructure To Support Clinical Research Professionals

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